Hydrate 2

Product NDC
43406-0716
11-digit product format
434060716
Labeler code
43406
Product ID
43406-0716_fb826b11-36a9-46d4-a4f9-350f76f06ade
Type
HUMAN OTC DRUG
Nonproprietary name
BerberisAquifolium,BetaVulgaris,Boldo,ChelidoniumMajus,HordeumVulgare,IrisVersicolor,RosmarinusOfficinalis,CarduusMarianus,TaraxacumOfficinale,AvenaSativa,EleutherococcusSenticosus,XanthoxylumFraxineum,EquisetumHyemale,HypericumPerforatum,UlmusFulva,GettysburgAqua,GlycyrrhizaGlabra,WildbadAqua,CarlsbadAqua,ATP,Hydrogen,NatrumMuriaticum,Oxygen,Silicea,WiesbadenAqua
Dosage form
LIQUID
Route
ORAL
Labeler
Natural Creations, Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-11-23
Substance
ADENOSINE TRIPHOSPHATE; AVENA SATIVA FLOWERING TOP; BERBERIS AQUIFOLIUM ROOT BARK; BETA VULGARIS; CHELIDONIUM MAJUS; ELEUTHEROCOCCUS SENTICOSUS WHOLE; EQUISETUM HYEMALE; GLYCYRRHIZA GLABRA; HORDEUM VULGARE WHOLE; HYDROGEN; HYPERICUM PERFORATUM; IRIS VERSICOLOR ROOT; MILK THISTLE; OXYGEN; PEUMUS BOLDUS LEAF; ROSMARINUS OFFICINALIS FLOWERING TOP; SILICON DIOXIDE; SODIUM CHLORIDE; TARAXACUM OFFICINALE; ULMUS RUBRA BARK; ZANTHOXYLUM AMERICANUM BARK
Active strength
30; 8; 8; 8; 8; 8; 8; 12; 8; 34; 8; 8; 8; 30; 8; 8; 30; 30; 8; 8; 8 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydrate 2
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVENA SATIVA FLOWERING TOP30 [hp_C]/mL
BERBERIS AQUIFOLIUM ROOT BARK8 [hp_X]/mL
BETA VULGARIS8 [hp_X]/mL
PEUMUS BOLDUS LEAF8 [hp_X]/mL
MILK THISTLE8 [hp_X]/mL
CHELIDONIUM MAJUS8 [hp_X]/mL
EQUISETUM HYEMALE8 [hp_X]/mL
ELEUTHEROCOCCUS SENTICOSUS WHOLE12 [hp_X]/mL
HORDEUM VULGARE WHOLE8 [hp_X]/mL
HYPERICUM PERFORATUM34 [hp_C]/mL
IRIS VERSICOLOR ROOT8 [hp_X]/mL
ROSMARINUS OFFICINALIS FLOWERING TOP8 [hp_X]/mL
TARAXACUM OFFICINALE8 [hp_X]/mL
ULMUS RUBRA BARK30 [hp_C]/mL
ZANTHOXYLUM AMERICANUM BARK8 [hp_X]/mL
GLYCYRRHIZA GLABRA8 [hp_X]/mL
ADENOSINE TRIPHOSPHATE30 [hp_C]/mL
HYDROGEN30 [hp_C]/mL
SODIUM CHLORIDE8 [hp_X]/mL
OXYGEN8 [hp_X]/mL
SILICON DIOXIDE8 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 21 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MA9CQJ3F7FInternal UNII lookup
VZJ9F3C3SBInternal UNII lookup
4G174V5051Internal UNII lookup
Q4EWM09M3OInternal UNII lookup
U946SH95EEInternal UNII lookup
7E889U5RNNInternal UNII lookup
59677RXH25Internal UNII lookup
ZX5Z2LW23OInternal UNII lookup
8JBE478M5QInternal UNII lookup
XK4IUX8MNBInternal UNII lookup
X43D4L3DQCInternal UNII lookup
8JM482TI79Internal UNII lookup
39981FM375Internal UNII lookup
91QY4PXU8QInternal UNII lookup
A4KL1HMZ7TInternal UNII lookup
2788Z9758HInternal UNII lookup
8L70Q75FXEInternal UNII lookup
7YNJ3PO35ZInternal UNII lookup
451W47IQ8XInternal UNII lookup
S88TT14065Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1122605f-715e-4f12-9d9d-a20442f9cd45Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43406-0716-2Hydrate 260 mL in 1 BOTTLE, DROPPERLIQUID602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43406-0716HYDRATE 2 (BERBERISAQUIFOLIUM,BETAVULGARIS,BOLDO,CHELIDONIUMMAJUS,HORDEUMVULGARE,IRISVERSICOLOR,ROSMARINUSOFFICINALIS,CARDUUSMARIANUS,TARAXACUMOFFICINALE,AVENASATIVA,ELEUTHEROCOCCUSSENTICOSUS,XANTHOXYLUMFRAXINEUM,EQUISETUMHYEMALE,HYPERICUMPERFORATUM,ULMUSFULVA,GETTYSBURGAQUA,GLYCYRRHIZAGLABRA,WILDBADAQUA,CARLSBADAQUA,ATP,HYDROGEN,NATRUMMURIATICUM,OXYGEN,SILICEA,WIESBADENAQUA) LIQUID [NATURAL CREATIONS, INC]1Current NDC, Legacy NDC, 1 package rows20211118_1122605f-715e-4f12-9d9d-a20442f9cd45.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrate 2BERBERISAQUIFOLIUM,BETAVULGARIS,BOLDO,CHELIDONIUMMAJUS,HORDEUMVULGARE,IRISVERSICOLOR,ROSMARINUSOFFICINALIS,CARDUUSMARIANUS,TARAXACUMOFFICINALE,AVENASATIVA,ELEUTHEROCOCCUSSENTICOSUS,XANTHOXYLUMFRAXINEUM,EQUISETUMHYEMALE,HYPERICUMPERFORATUM,ULMUSFULVA,GETTYSBURGAQUA,GLYCYRRHIZAGLABRA,WILDBADAQUA,CARLSBADAQUA,ATP,HYDROGEN,NATRUMMURIATICUM,OXYGEN,SILICEA,WIESBADENAQUANatural Creations, Inc1122605f-715e-4f12-9d9d-a20442f9cd452025-12-16WarningsExact identifier
ndc (product): 43406-0716

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43406-0716-24340607160260 mL in 1 BOTTLE, DROPPER (43406-0716-2) 60 ml2015-11-230000-00-00NoNoCurrent